Insight: Biology Of A Meningococcal Vax Company

Chiron Corporation. Does that name a ring a bell? In North America, it’s gone from barely known to highly recognized in less than a month since 45 million doses of flu
vaccine made by the company in its British factory, were found to be contaminated. In Brazil the company made headlines
when over 5 million doses of a vaccine were recalled following serious adverse reactions.

New Zealanders will be familiar with Chiron Corporation – It is the company overseeing our meningococcal B vaccine
(MeNZB™) trials. They are also manufacturing the vaccine and selling it back to our government. Aside from the conflicts
of interest inherent in this arrangement, Chiron’s problems in North America and Brazil surfaced after New Zealand
experts, prior to the approval of the MeNZB™ vaccine, had expressed concerns.

While the flu vaccine saga is a maze of PR pronouncements, public assurances, backtracks, and yet more spin, the company
has just received a grand jury subpoena. The newspaper USA Today said the subpoena raises the stakes in the USA's flu
vaccine crisis to a possible criminal matter. Legal experts said the Justice Department might be looking for evidence of
securities fraud -whether the company intentionally misled investors. The department could also be investigating whether
Chiron lied to a government agency, such as the Food and Drug Administration (FDA), legal experts said.

A small war has flared up between the FDA and Britain’s Medicines and Healthcare products Regulatory Agency (MHRA). The
MHRA said they warned their American counterparts about on-going problems with Chiron in August. British officials also
said that the United States "should have realized the potential scale" of problems at the Liverpool plant long before
the announcement of the suspension of Chiron's license. But as the New York Times reported recently contamination
problems at the factory were not new. Polio vaccines manufactured by a previous owner were recalled in October 2000
after fears of BSE (Mad Cow disease) contamination. While a previous flu vaccine manufacturer also had contamination
problems at the same factory in 1999. It has been noted that the adverse events following immunization with Chiron’s MMR
vaccine in Brazil were from a vaccine made in the same Italian factory that produces New Zealand’s experimental MeNZB™
vaccine.

The UK Guardian characterized the FDA’s reaction to the Chiron flu vaccine contamination as ‘hand-wringing about why it
didn’t act earlier.’ But then given other recent situations, such as the documents discovered by The Wall Street Journal
that show safety concerns surrounding Vioxx use have been systematically covered up since at least 2000, to a string of
other cases where the agency failed to safeguard the public, it’s not surprising. In a recent expose in Harpers Magazine
the situation was described succinctly as the FDA’s ‘deference to drug companies.’ Meanwhile the Financial Times of
London and The Washington Post reported that the US Senate Finance Committee is expanding its probe of the FDA and its
secret deals with drug manufacturers.

In New Zealand, the medicines watchdog, MedSafe, has received 60% more reports of adverse effects relating to Vioxx’s
competitor, Celebrex, than Vioxx, and yet, paradoxically says there is no official evidence of Celebrex being unsafe, or
any intention to take the findings further.

The Chiron debacle does have an upside. It has given the public an insight into how a biotech company works to spin its
woes into gold and how little stands in the way of Chiron’s drive for shareholder profit (last year vaccines accounted
for about US $700 million of Chiron’s US $1.75 billion in revenue). It’s also given an insight into the cosy
relationship between the regulators and their clients, the pharmaceutical industry.

In New Zealand documents obtained under the Official Information Act show that the New Zealand Medicines Assessment
Advisory Committee (MAAC), appointed by the Minister to advise her on the licensing of new drugs, had concerns about the
manufacturing and quality of the MeNZB™ vaccine. While the Committee noted that there are a “…number of issues relating
to the manufacturing and quality data that are to be addressed by Chiron,” the Minister approved the license for the
MeNZB vaccine under the fast-track section 23 of the Medicines Act the very next day. Section 23 allows for license of
experimental drugs for “restricted use and limited numbers of patients.”

Despite the concerns, MedSafe arbitrarily extended the expiry date on 390,000 doses of the MeNZB™ vaccine so that it
could be used in the vaccination program. Paradoxically, MedSafe’s website advises consumers not to have the MeNZB™
vaccine if “the expiry date printed on the pack has passed.”

The minutes of the MAAC meeting show that the teleconference meeting was called at such short notice that several of the
committee of could not be contacted, and several others had not received the clinical data upon which the approval
decision was based. The media had mentioned the planned meeting two weeks earlier.

When the Minister was asked in Parliament if she had confidence in the MAAC recommendation, she said that she didn’t
have to because the New Zealand vaccine data had been given the nod by the UK’s MHRA.

This is the same MHRA that sat on evidence of SSRI drugs, such as Aropax, causing an increase in the risk of youth
suicide for more than a decade without taking regulatory action, and which is a central figure in the UK Parliament's
current inquiry into the influence of the pharmaceutical industry on healthcare.

The situation with Chiron is far from reassuring for the 1.15 million children presently being immunized with the
experimental MeNZB™ vaccine in New Zealand. While immunization is still voluntary in New Zealand, spend any time at a
school in South Auckland and you’ll discover the pressure to immunize feels very compulsory. Combine that with a lack of
information other than MOH glossy brochures and the lack of critical analysis of the MeNZB™ vaccine in the mainstream
media or even publicizing of information like the fact that every year about 350 New Zealand children aged under two,
die from all causes; 99.5% of them unrelated to meningococcal disease.

The minister has confirmed in Parliament that meningococcal disease is naturally declining. This year the death rate is
about 75% less than peak levels. And yet in the same breath the minister says this is not significant and does not
represent evidence that the epidemic is abating. At the same time, the Land Transport Safety Authority was publicly
crowing about the success of its ‘anywhere, anytime’ speed camera policy; claimed to have resulted in a “significant”
12% decline in road deaths. The Ministry of Health’s own data shows that meningococcal disease cases are at 10 year
lows; deaths are at thirteen year lows and yet the minister continues to deny that there is any evidence that the
epidemic is abating naturally.

Interestingly MAAC noted that the benefits of the MeNZB™ vaccine only applied in the Auckland context, yet the mass
vaccination experiment is still being rolled out nationwide and given the Ministry of Health’s own data, is unlikely to
prevent more than 1 or 2 deaths out of a total of 27,000 deaths in New Zealand each year.

At this stage one wonders just where the MOH should go to seek reassurance that its $250 million investment is not lost.
Neither Chiron nor those running the trials with Chiron’s money seem to be a good choice. That leaves MedSafe. But like
the FDA and the MHRA, their conflicted political agendas may not, in fact make them the best judge of a vaccine’s safety
or effectiveness.

Official press releases continue to assure parents that the MeNZB™ vaccine is not only needed, but safe. On 7 July the
minister stated, “MedSafe is assured that the vaccine is safe and effective...” A day earlier, the MAAC said that it
‘appeared to be’ effective ‘in the Auckland context, ’ and a few weeks before that the MOH said that rollout of the
programme will occur knowing that MeNZB™ is immunogenic “but without efficacy data.” That means they don’t actually
don’t know if it’s effective. A number of observational studies are planned post-licensure to assess effectiveness of
the vaccine, but the dramatic ongoing declines in meningococcal disease case numbers and deaths occurring naturally will
complicate that exercise.

The big question is of course: just where do parents go for the objective reassurance they so desperately need?

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